Ixekizumab met all primary and key secondary objectives across three pivotal studies of 3,866 patients, the largest Phase 3 moderate-to-severe plaque psoriasis program to date

Ixekizumab was superior to etanercept on all measures of skin clearance in both active comparator studies

Lilly plans regulatory submissions for ixekizumab in 1st half of 2015

Eli Lilly and Company's (NYSE: LLY) investigational medicine ixekizumab was statistically superior to etanercept and placebo on all skin clearance measures in Phase 3 studies, the company said today in disclosing top-line results from its pivotal UNCOVER studies in moderate-to-severe plaque psoriasis.

"These data are important for people suffering from moderate-to-severe plaque psoriasis, as up to 41 percent of those treated with ixekizumab were able to achieve clear skin at week 12, with just one injection per dose. These results give us confidence that if approved, ixekizumab could make complete resolution of psoriasis possible for significantly more people," said David Ricks, Lilly senior vice president, and president, Lilly Bio-Medicines.

Study design In the three UNCOVER studies, patients were assigned to receive either placebo or ixekizumab (80 mg every two or four weeks) for 12 weeks, following a 160 mg starting dose. In the two active comparator studies (UNCOVER-2 and 3), patients could be assigned to receive etanercept 50 mg twice weekly for 12 weeks. In UNCOVER-1, responders to treatment were assigned to continue treatment on either placebo or ixekizumab (80 mg every 4 or 12 weeks) for up to 60 weeks.

Results Patients treated with both dosing regimens of ixekizumab had significantly greater levels of skin clearance compared to placebo and to etanercept at the 12-week endpoint. Skin clearance was measured by standard primary endpoints for psoriasis studies: the Psoriasis Area and Severity Index (PASI) and the Static Physician Global Assessment (sPGA).

For patients treated with ixekizumab either every four weeks or every two weeks, between 78 to 90 percent of patients achieved at least a 75 percent reduction in PASI score (PASI 75) at 12 weeks. Additionally, 31 to 41 percent of these patients achieved PASI 100, or clear skin, at week 12. For comparison, between 5 to 7 percent of patients treated with etanercept in the UNCOVER-2 and 3 studies achieved PASI 100.

Statistically significant improvements in skin clearance measures for patients treated with ixekizumab were observed as early as the first week when compared to either placebo or etanercept, and continued through week 12. In the UNCOVER-1 study, high levels of response were maintained through 60 weeks of treatment.

Adverse events were comparable for patients receiving ixekizumab in the 12-week, randomized control portion across all three studies. The overall rates and severities of adverse events observed were comparable to those for etanercept in the two active comparator trials. The most frequently reported events (more than five percent across all three studies) were nasopharyngitis and injection site reaction. Most injection site reactions were mild, and most patients who experienced an injection site reaction continued treatment with ixekizumab.

"Moderate-to-severe plaque psoriasis can have a devastating life impact for patients," Ricks said. "Clear skin is their goal, but many patients are not able to achieve complete resolution using currently-available treatments."

Lilly plans to submit full data from the UNCOVER studies for disclosure at scientific meetings and in peer-reviewed journals in 2015. The company intends to submit ixekizumab to regulatory authorities in the first half of 2015.

"Ixekizumab was discovered and engineered to achieve high affinity and specificity to the IL-17A cytokine by Lilly Research Laboratories scientists, and is the most advanced asset in Lilly's pipeline of biotechnology-based medicines for the treatment of autoimmune diseases," said Tom Bumol, Ph.D., senior vice president of biotech discovery research, Lilly Research Laboratories, and president, Applied Molecular Evolution. "These data appear to confirm our hypothesis -- that IL-17A is a major driver of excess keratinocyte (skin cell) proliferation and activation in psoriasis. We're encouraged that this discovery by Lilly scientists could provide a new treatment option for patients with moderate-to-severe plaque psoriasis."

About the UNCOVER studies Patients enrolled in the UNCOVER studies had a confirmed diagnosis of chronic plaque psoriasis for at least six months prior to randomization. Additionally, at screening and at randomization they demonstrated at least 10 percent Body Surface Area (BSA) of psoriasis, an sPGA score of at least 3 and PASI score of at least 12. UNCOVER-1 compared the safety and efficacy of different dosing regimens of ixekizumab to placebo after 12 weeks and 60 weeks of treatment. UNCOVER-2 and 3 evaluated different dosing regimens of ixekizumab compared to either placebo or etanercept for 12 weeks.

About ixekizumab Ixekizumab is a monoclonal antibody with high affinity and specificity that binds to and neutralizes the pro-inflammatory cytokine interleukin-17A (IL-17A). In psoriasis, IL-17A plays a major role in driving excess keratinocyte (skin cell) proliferation and activation. Ixekizumab does not bind to cytokines IL-17B, IL-17C, IL-17D, IL-17E or IL-17F. Ixekizumab is administered via subcutaneous injection (under the skin). Ixekizumab is also in clinical development for the treatment of psoriatic arthritis.

About Moderate-to-Severe Plaque Psoriasis Psoriasis is a chronic, noncontagious autoinflammatory disease that appears on the skin. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells.[i] It is the most common inflammatory disease in the United States, affecting as many as 7.5 million Americans and an estimated 125 million people worldwide.[ii] Psoriasis can occur on any part of the body and is associated with other serious health conditions, such as diabetes and heart disease.[iii],[iv]

The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells. Approximately 17 percent of psoriasis patients have moderate-to-severe plaque psoriasis.[v]

About Eli Lilly and Company Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.

P-LLY

This press release contains forward-looking statements about ixekizumab as a potential treatment for moderate-to-severe plaque psoriasis and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

Mobile, social, Big Data, and cloud have fundamentally changed the way we live. “Anytime, anywhere” access to data and information is no longer a luxury; it’s a requirement, in both our personal and professional lives. For IT organizations, this means pressure has never been greater to deliver meaningful services to the business and customers.

Digital Transformation is the ultimate goal of cloud computing and related initiatives. The phrase is certainly not a precise one, and as subject to hand-waving and distortion as any high-falutin' terminology in the world of information technology.
Yet it is an excellent choice of words to describe what enterprise IT—and by extension, organizations in general—should be working to achieve.
Digital Transformation means:
handling all the data types being found and created in the organizat...

SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.

Chuck Piluso presented a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions.
Prior to Secure Infrastructure and Services, Mr. Piluso founded North American Telecommunication Corporation, a facilities-based Competitive Local Exchange Carrier licensed by the Public Service Commission in 10 states, serving as the company's chairman and president from 1997 to 2000.
Between 1990 and 1997, Mr. Piluso served as chairman & founder of International Te...

The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016.
Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one.
In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...

Container technology is sending shock waves through the world of cloud computing. Heralded as the 'next big thing,' containers provide software owners a consistent way to package their software and dependencies while infrastructure operators benefit from a standard way to deploy and run them. Containers present new challenges for tracking usage due to their dynamic nature. They can also be deployed to bare metal, virtual machines and various cloud platforms. How do software owners track the usag...

SYS-CON Events announced today that MobiDev, a software development company, will exhibit at the 17th International Cloud Expo®, which will take place November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
MobiDev is a software development company with representative offices in Atlanta (US), Sheffield (UK) and Würzburg (Germany); and development centers in Ukraine. Since 2009 it has grown from a small group of passionate engineers and business managers to a full-scale mobi...

With SaaS use rampant across organizations, how can IT departments track company data and maintain security? More and more departments are commissioning their own solutions and bypassing IT. A cloud environment is amorphous and powerful, allowing you to set up solutions for all of your user needs: document sharing and collaboration, mobile access, e-mail, even industry-specific applications.
In his session at 16th Cloud Expo, Shawn Mills, President and a founder of Green House Data, discussed h...

For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space.
In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducte...

There are many considerations when moving applications from on-premise to cloud. It is critical to understand the benefits and also challenges of this migration. A successful migration will result in lower Total Cost of Ownership, yet offer the same or higher level of robustness.
In his session at 15th Cloud Expo, Michael Meiner, an Engineering Director at Oracle, Corporation, analyzed a range of cloud offerings (IaaS, PaaS, SaaS) and discussed the benefits/challenges of migrating to each offe...

One of the hottest areas in cloud right now is DRaaS and related offerings.
In his session at 16th Cloud Expo, Dale Levesque, Disaster Recovery Product Manager with Windstream's Cloud and Data Center Marketing team, will discuss the benefits of the cloud model, which far outweigh the traditional approach, and how enterprises need to ensure that their needs are properly being met.

In their session at 17th Cloud Expo, Hal Schwartz, CEO of Secure Infrastructure & Services (SIAS), and Chuck Paolillo, CTO of Secure Infrastructure & Services (SIAS), provide a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions.
In his role as CEO of Secure Infrastructure & Services (SIAS), Hal Schwartz provides leadership and direction for the company.

In a recent research, analyst firm IDC found that the average cost of a critical application failure is $500,000 to $1 million per hour and the average total cost of unplanned application downtime is $1.25 billion to $2.5 billion per year for Fortune 1000 companies. In addition to the findings on the cost of the downtime, the research also highlighted best practices for development, testing, application support, infrastructure, and operations teams.

"We've just seen a huge influx of new partners coming into our ecosystem, and partners building unique offerings on top of our API set," explained Seth Bostock, Chief Executive Officer at IndependenceIT, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.

The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.

As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart syste...

Digital Transformation is the ultimate goal of cloud computing and related initiatives. The phrase is certainly not a precise one, and as subject to hand-waving and distortion as any high-falutin' terminology in the world of information technology.
Yet it is an excellent choice of words to describe what enterprise IT—and by extension, organizations in general—should be working to achieve.
D...

DevOps is first and foremost a mindset – any DevOps initiative must begin with a cultural change. Last Tuesday, I participated in an online panel on the subject of Implementing a DevOps Culture, as part of Continuous Discussions (#c9d9), a series of community panels about Agile, Continuous Delivery and DevOps. Watch a recording of the panel:
Continuous Discussions is a community initiative by Ele...

“Dad, if my character dies in the game, would I die in the real world?”
What a beautifully naive question that my son, Trevor, asked me during a son-dad conversation about how games might change over the years.
Earlier last year, Mattel’s CEO, Bryan Stockton, was fired. After three years, it was clear that Mattel was continuing to be challenged with sales weakness, and lower gross margins, which...

You often hear the two titles of "DevOps" and "Immutable Infrastructure" used independently.
In his session at DevOps Summit, John Willis, Technical Evangelist for Docker, covered the union between the two topics and why this is important. He provided an overview of Immutable Infrastructure then showed how an Immutable Continuous Delivery pipeline can be applied as a best practice for "DevOps." ...

The majority of an organization’s revenues are dependent on suppliers, distributors and other third parties. But as Benjamin M. Lawsky, New York State’s Superintendent of Financial Services, points out: “Unfortunately, those third-party firms can provide a back-door entrance to hackers who are seeking to steal sensitive bank customer data.”
By now most everyone is well aware of the major data bre...

Conservation International (CI) in Arlington, Virginia uses new technology to pursue more data about what's going on in tropical forests and other ecosystems around the world.
As a non-profit, they have a goal of a sustainable planet, but we're going to learn how they've learned to measure what was once unmeasurable -- and then to share that data to promote change and improvement.

The concept behind the Internet of Things has been around for a while now, ATMs being some of the first enterprise, hardened, network-connected, managed devices for mainstream consumer use. So too with our mobile phones, these are not new concepts to network technicians or hardware geeks. But for the rest of us, we simply never imagined the extents that the "ubiquity of connectedness" would take a...

Tableau Software and big data analytics platforms come together to provide visualization benefits for those seeking more than just crunched numbers.
The next BriefingsDirect big data innovation discussion highlights how Tableau Software and big data analytics platforms come together to provide visualization benefits for those seeking more than just crunched numbers. They're looking for ways to im...

Business and IT leaders today need better application delivery capabilities to support critical new innovation. But how often do you hear objections to improving application delivery like, "I can harden it against attack, but not on this timeline"; "I can make it better, but it will cost more"; "I can deliver faster, but not with these specs"; or "I can stay strong on cost control, but quality wil...

The Federal Government’s “Cloud First” policy mandates that agencies take full advantage of cloud computing benefits to maximize capacity utilization, improve IT flexibility and responsiveness, and minimize cost. The Federal Risk and Authorization Management Program (FedRAMP) is a mandatory government-wide program that provides a standardized approach to security assessment, authorization, and con...

Do the ‘darker’ channels and means that exist for searching the web in anonymity ultimately spell doom for the wider march towards open data?
So-called ‘open data’ is supposed to be an instrument for breaking down information gaps across industries and letting companies share benchmarks and best practices that raise productivity – all information should be open and that should (theoretically) inc...

Learn how the IoT Cloud will power the world of tomorrow and why managing IoT through the cloud is as important as cloud computing itself. Learn how the devices of tomorrow will work on business models that reflect a new business strategy and a way to consume services.
In his session at @ThingsExpo, Ian Khan, Manager, Innovation & Marketing at Solgenia, will discuss how powered by the cloud and...

Technology changes at the speed of light. To say it can be hard to keep up is an understatement. For performance engineers, taking charge of your own continuing education is one of the most important things you can do to remain at the top of your game.

JavaScript is primarily a client-based dynamic scripting language most commonly used within web browsers as client-side scripts to interact with the user, browser, and communicate asynchronously to servers.
If you have been part of any web-based development, odds are you have worked with JavaScript in one form or another. In this article, I'll focus on the aspects of JavaScript that are releva...

The Internet of Things (IoT) has quickly become the next “be all to end all” in information technology. Touted as how cloud computing will connect everyday things together, it is also feared as the real- life instantiation of The Terminator’s Skynet, where sentient robot team with an omnipresent and all-knowing entity that uses technology to control, and ultimately destroy, all of humanity.

As a recent graduate, and now professor in the University of Connecticut's Business Analytics and Project Management masters program, I have a lot of conversations surrounding the topic of "Big Data" and questions such as, "What does that term actually mean?"
Big Data is a fairly new topic and what seems to be an elusive term for many. Conversations are important to help bring clarity to Big Data...

Most developers learn best by examples, which naturally tend to simplify matters and omit things that aren’t essential for understanding. This means that the “Hello World” example, when used as starting point for an application, may be not suitable for production scenarios at all.
I started using Node.js like that and I have to confess that it took me almost two years to quantify the huge perform...

Knowledge management, in business terms, refers to saving, developing, sharing, and effectively using knowledge for the benefit of organization. It refers to a multi-disciplined approach of achieving organizational objectives by making the best use of knowledge.
Scientia potentia est (Latin proverb meaning "knowledge is power") attributed to 16th century philosopher Sir Francis Bacon is nowadays ...

Cloud computing budgets worldwide are reaching into the hundreds of billions of dollars, and no organization can survive long without some sort of cloud migration strategy. Each month brings new announcements, use cases, and success stories.